DURING A LAPAROSCOPIC GASTRIC BAND PROCEDURE, A RETRACTION SHEATH WAS TORN APART. IT IS NOTED THAT THE DEVICE WAS USED INCORRECTLY, OUTSIDE THE LABELED INSTRUCTIONS FOR USE. THE SURGEON ELECTED TO USE THE RETRACTION SHEATH AS AN INTRODUCTION SHEATH. INVESTIGATION HAS INDICATED THAT THE SURGEON PURPOSEFULLY CHOSE TO USE THE RETRACTION SHEATH FOR INSERTION. THE SURGEON WAS ABLE TO RETRIEVE THE TORN SHEATH AND ALL PARTS WERE ACCOUNTED FOR. NO INJURY OR IMPACT TO THE PATIENT WAS REPORTED.
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Patient 1
THE INVESTIGATION PERFORMED WAS INTENDED TO EVALUATE THE MANUFACTURING PROCESS FOR DEFECTS AND ATTEMPT TO RECREATE THE FAILURE. FIRST THE COMPANY QA UNIT REVIEWED AND WITNESSED THE MANUFACTURING PROCESS TO EVALUATE WHETHER DEFECTS MIGHT HAVE BEEN INTRODUCED INTO THE SHEATH. OTHER SHEATH INVENTORY WAS CHECKED FOR POSSIBLE DEFECTS TO ATTEMPT TO IDENTIFY A ROOT CAUSE. NO CAUSE FOR THE FAILURE MODE RELATED TO MANUFACTURING COULD BE IDENTIFIED. BECAUSE THE DEVICE WS NOT RETURNED AND THE DESCRIPTION OF THE FAILURE MODE WAS SO UNUSUAL, THE COMPANY ATTEMPTED TO 'RECREATE' THE FAILURE MODE BY REPEATING THE STEPS USED BY THE SURGEON AS RECOUNTED BY THE SURGICAL SALES REP. THE ACTUAL FAILURE COULD NOT BE REPRODUCED. THERE HAVE NEVER BEEN ANY OTHER SIMILAR FAILURES EITHER WITHIN VERIFICATION AND VALIDATION TESTING OR FROM OTHER CUSTOMER COMPLAINTS. IT IS SURMISED THAT THE SURGEON 'ROLLED UP' THE SHEATH WITHIN A SEPARATE TROCAR AND THEN TRIED TO PUSH THE SPIDER DEVICE INTO THE OPENING, POSSIBLY TANGLING THE INSTRUMENT DELIVERY TUBES WITHIN THE SHEATH, THEREBY STRETCHING AND TEARING THE SHEATH.